Long - Term Follow Up of Sickle Cell Disease and Beta-thalassemia Subjects Previously Exposed to BIVV003 or ST-400.
NCT ID: NCT05145062
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
8 participants
OBSERVATIONAL
2021-12-21
2038-07-14
Brief Summary
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Long-term safety of BIVV003 in participants with severe sickle cell disease (SCD) and ST- 400 in participants with transfusion-dependent beta-thalassemia (TDT)
Secondary Objectives:
* Long-term efficacy of the biological treatment effect of BIVV003 in SCD
* Long-term efficacy of the clinical treatment effect of BIVV003 on SCD-related clinical events
* Long-term efficacy of the biological treatment effect of ST-400 in TDT
* Long-term efficacy of the clinical treatment effect of ST-400 in TDT
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BIVV003 Cohort
All participants treated in parent and future studies with BIVV003
BIVV003
Solution for intravenous administration
ST-400 Cohort
All participants treated in parent studies with ST-400
ST-400
Solution for intravenous administration
Interventions
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BIVV003
Solution for intravenous administration
ST-400
Solution for intravenous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Capable of giving signed informed consent (and if applicable assent)
Exclusion Criteria
* Any other reason that, in the opinion of the Investigator or Medical Monitor, would render the participant unsuitable for participation in the study The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
18 Years
45 Years
ALL
No
Sponsors
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Sangamo Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Sangamo Therapeutics
Locations
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UCSF Benioff Children's Hospital
Oakland, California, United States
University of California Davis Health System
Sacramento, California, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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LTS16653
Identifier Type: -
Identifier Source: org_study_id